EMBARGOED FOR RELEASE UNTIL MAY 1, 1998
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UCSD STUDY SHOWS PRESCRIPTION SLEEPING PILLS ASSOCIATED WITH INCREASED DEATH RISK
Researchers at the University of California, San Diego (UCSD) School of Medicine report an association between the use of prescription sleeping pills and an increased risk of death. The research findings are published in the May 1, 1998, issue of the journal Biological Psychiatry.
In controlling only for age and gender, the researchers found that men and women who reported using sleeping pills at least 30 times per month were about three times more likely to die within a 6-year follow-up period than non-users. When they considered 31 factors that might account for the increased death rates -- such as age, exercise, smoking, heart disease and cancer -- the risk was reduced but remained significant, at about 1.29 times, or 29 percent above, normal. Further, the researchers found that even occasional use of sleeping pills was associated with increased risk of death (about 8 percent above normal).
"Overall, the hazard associated with taking sleeping pills at least 30 times a month was similar to the hazard of smoking one to two packs of cigarettes per day," said Daniel F. Kripke, M.D., professor of psychiatry at UCSD School of Medicine and lead author on the paper.
The authors note important limitations of the study. "Demonstration of an association of increased death rates with sleeping pill use does not prove that the sleeping pills caused the deaths," Kripke said. "Also, this study did not identify which particular sleeping pills the participants were taking. It is possible that some sleeping pills carry a mortality risk and that others are safe."
Zolpidem, the most popular sleeping pill today, was not used in the U.S. during the study period, so these results do not apply to zolpidem. At the time the study was done, flurazepam, temazepam and triazolam were the most popular sleeping pills. Kripke also notes that different statistical methods provide different estimates of the amount of risk. The method controlling only for age and gender may have overestimated the risk, while controlling for 31 factors may have underestimated the risk. The only way to determine if any of the currently available sleeping pills are safe and effective for long-term use is through controlled clinical trials. "Millions of Americans use sleeping pills," Kripke said. "These pills have been approved by the FDA for short-term use, but the data indicate that most are consumed by people who use them almost nightly for many years. Testing for long-term safety is urgently needed by patients and their physicians."
The data were obtained from the Cancer Prevention Study II of the American Cancer Society, in which roughly 1.1 million participants were followed prospectively from 1982 to 1988. The survey was designed primarily to study cancer risks such as cigarette smoking, but information on use of prescription sleeping pills was included.
Among the 473,673 men included in the analyses, 48.6 percent reported no use of sleeping pills, 48.7 percent left the item blank, 2.3 percent reported usage fewer than 30 times per month, and 0.4 percent reported usage at least 30 times per month. Among the 626,157 women included in the analyses, 46.9 percent reported no use, 49.2 percent left the item blank, 3.4 percent reported usage fewer than 30 times per month, and 0.5 percent reported usage at least 30 times per month. Participants reporting usage at least 30 times per month reported 65 percent of total monthly sleeping pills consumed. Co-authors are Melville R. Klauber, Ph.D., and Deborah L. Wingard, Ph.D., of the UCSD Department of Family and Preventive Medicine; Robert L. Fell and Joseph D. Assmus of the UCSD Department of Psychiatry; and Lawrence Garfinkel of the American Cancer Society. This research was supported by the American Cancer Society and the Weingart Foundation.
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